Tarsus Pharmaceuticals has completed its acquisition of Alkeus Pharmaceuticals, adding worldwide rights to gildeuretinol acetate, or ALK-001, an investigational oral treatment for Stargardt disease.
Alkeus is a privately held biotechnology company focused on retinal diseases. Tarsus announced the acquisition on Aug. 6 and said the transaction closed after customary conditions in the merger agreement were satisfied. The company did not disclose financial terms in its completion announcement.
Gildeuretinol is a once-daily oral small molecule designed to reduce the accumulation of toxic vitamin A dimers in the retina while preserving the normal visual cycle. Tarsus said the medicine has shown a promising tolerability and efficacy profile in more than 400 people studied to date.
The candidate is being evaluated in the global Phase III NORTHSTAR trial for Stargardt disease, with topline data anticipated in 2029. The FDA has granted the program Breakthrough Therapy, Orphan Drug, Fast Track and Rare Pediatric Disease designations.
Stargardt disease is a rare inherited retinal disease that progressively damages the macula, the part of the retina responsible for detailed central vision. Symptoms frequently begin in childhood or early adulthood and can impair reading, face recognition, driving and independent living.
Tarsus estimates Stargardt disease may affect as many as 86,000 people in the United States, with more than 36,000 clinically diagnosed. There are no FDA-approved therapies for the disease.
The acquisition expands Tarsus’ eye-care pipeline. The company markets XDEMVY, or lotilaner ophthalmic solution 0.25%, in the United States for Demodex blepharitis. Its other development programs include TP-04 for ocular rosacea, TP-05 for potential Lyme-disease prevention and IRX-101, an investigational ocular antiseptic.
Bobby Azamian, Tarsus’ chief executive officer and chairman, said the company will focus on advancing NORTHSTAR and integrating Alkeus. He described gildeuretinol as complementary to Tarsus’ eye-care strategy and a potential treatment for patients with Stargardt disease.
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